- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06014567
Twins MR Imaging Study
Characterising Biomarkers of Disease and Ageing in Twins Using Magnetic Resonance Imaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND Diverse interactions between environmental, genetic, and epigenetic factors shape individual paths of ageing and disease. In young adulthood, twins are highly similar in most organ structures, but their similarity decreases over time as they are progressively exposed to different environments. Twin studies provide an ideal way to investigate how the body ages and how age-related diseases (such as Alzheimer's disease, heart failure, fatty liver disease, and cancer) develop. Magnetic Resonance Imaging (MRI) is a type of scan that produces detailed images of the inside of the body. MRI enables non-invasive and safe visualisation of age and disease-related changes in the body, often long before clinical symptoms are perceived. MRI-derived biological features/biomarkers can be used to understand the influence of environmental exposures on ageing and disease.
PARTICIPANTS 2500 adult (age 18 and older) volunteers of TwinsUK, the UK's largest adult twin Biobank and the most clinically detailed globally, will be invited to participate. Interested individuals will complete screening to confirm study eligibility and their safety for MRI scanning. Eligible participants will complete informed consent prior to undertaking research MRI scans of their brain, spine, heart, abdomen and parts of their skeleton and muscles. 350 twins with differences in their data will be invited to repeat the MRI scans about two years later to explore longitudinal multi-organ imaging correlates of key environmental exposures based on cross-sectional signals and existing literature.
PROCEDURES Two 45-minute MRI scans of (1) the head and spine and (2) the abdomen to the upper thigh.
OUTCOMES Imaging-derived measures of morphology and function of the brain, spine, abdominal organs and musculoskeletal tissue. These measures will be used to identify twin pair differences related to ageing and disease. A comprehensive repository of MRI data will be created using protocols harmonised with the UK biobank. This will facilitate subsequent linkage with concurrently acquired samples and historic exposome data in longitudinal twin cohort.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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London, United Kingdom, SE1 7EH
- King's College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Identical or non-identical twins
- Gender: Male or Female
- Age: 18 years or above at the time of recruitment
- Must be able to understand the study information and provide informed consent
- Participation in the TwinsUK Biobank
Exclusion Criteria:
- Pregnancy
- Unable to tolerate MRI Procedures, e.g., claustrophobia, severe anxiety
- Contraindication to MRI Scanning, e.g., presence of non-MR conditional implants
- Any additional condition declared voluntarily by the participant that the principal investigator (PI) deems likely to affect the study's outcome.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BrainAGE score
Time Frame: At time of scan (duration 45 mins)
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BrainAGE will be calculated using MRI-derived phenotypes of brain volumetric changes (Cole et al, 2017).
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At time of scan (duration 45 mins)
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BodyAGE score
Time Frame: At time of scan (duration 45 mins)
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BodyAGE will be calculated using MRI-derived phenotypes of organ and tissue changes in the heart, liver, pancreas, kidneys, spine and muscle (Linge et al, 2018).
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At time of scan (duration 45 mins)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Claire Steves, King's College London
Publications and helpful links
General Publications
- Cole JH, Poudel RPK, Tsagkrasoulis D, Caan MWA, Steves C, Spector TD, Montana G. Predicting brain age with deep learning from raw imaging data results in a reliable and heritable biomarker. Neuroimage. 2017 Dec;163:115-124. doi: 10.1016/j.neuroimage.2017.07.059. Epub 2017 Jul 29.
- Linge J, Borga M, West J, Tuthill T, Miller MR, Dumitriu A, Thomas EL, Romu T, Tunon P, Bell JD, Dahlqvist Leinhard O. Body Composition Profiling in the UK Biobank Imaging Study. Obesity (Silver Spring). 2018 Nov;26(11):1785-1795. doi: 10.1002/oby.22210. Epub 2018 May 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 322446
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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